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the fda compliance policy guide (cpg) section . according to the cpg , these "copies" are considered to be unapproved new drugs and the fda believes that they fall "outside the bounds of traditional pharmacy practice" and are in violation of the federal food, drug, and cosmetic act. as a result, a director...
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lack of specific usp standards raised potential for varied interpretations by nuclear medicine practitioners and confusion across the industry. for more than a decade, radiopharmaceuticals have fallen under the standards of usp general chapter pharmaceutical compounding — sterile preparations. and like...
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